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Young Silver Fluoride Hypersensitivity Varnish is indicated for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Young Silver Fluoride Hypersensitivity Varnish is a formulation of silver, sodium fluoride, chitosan, acetic acid, and purified water intended for the treatment of dental hypersensitivity in adults. It is intended for professional use only.

Like other 510(k) cleared dental hypersensitivity varnishes including the predicate device, the proposed device works by physically occluding dentinal tubules through its silver and fluoride components. It contains small silver particles to facilitate their entry into the dentinal tubules, as well as chitosan and acetic acid to evenly disperse the solution. The product is supplied in a 10mL bottle with a dropper dispensing tip.

One to two drops of the varnish can treat up to 8 sites. If needed, a second application of the varnish may be administered after 1 week.

The provided text describes a 510(k) submission for a dental varnish. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a full clinical efficacy study with acceptance criteria often associated with AI/software medical devices. Therefore, the information needed to answer the questions about acceptance criteria for AI/software device performance is not present in this document.

The document discusses performance testing in a general product development sense (e.g., bench testing, biocompatibility, shelf life) to show the new device performs "as well or better than" the predicate, but these are not the quantitative acceptance criteria for AI model performance (e.g., sensitivity, specificity, AUC) that the prompt is looking for.

Specifically, there is no mention of:

1. Acceptance criteria table for AI performance: The document does not define specific metrics (e.g., sensitivity, specificity, accuracy) for an AI model.
2. Study proving device meets acceptance criteria: There is no clinical study described that evaluates an AI model's performance on a test set. The "study" mentioned refers to bench testing (dentinal occlusion, ion release) and biocompatibility for a physical dental varnish.
3. Sample size for a test set or data provenance: No test set of patient data for AI model evaluation is discussed.
4. Number of experts or qualifications for ground truth: No expert review for labeling images/data for AI training or testing is mentioned.
5. Adjudication method for a test set: Not applicable as there's no AI test set.
6. MRMC comparative effectiveness study: No study involving human readers with and without AI assistance is described.
7. Standalone (algorithm only) performance: Not applicable as it's not an AI algorithm.
8. Type of ground truth used: For a physical dental varnish, ground truth would relate to its physical and chemical properties, not diagnostic outcomes based on expert consensus or pathology data for an AI.
9. Sample size for training set, or how its ground truth was established: Not applicable as there's no AI training set.

In conclusion, the provided document does not contain the information requested because it pertains to a chemical dental product (varnish) and its 510(k) clearance based on substantial equivalence, not an AI/software medical device.

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